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Evaluation of TAVR Using the NAVITOR Valve in a Global Investigation

NCT04788888 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 434

Last updated 2026-04-13

Study results available
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Summary

Evaluation of TAVR using the NAVITOR valve in a Global Investigation.

Conditions

  • Symptomatic Severe Aortic Stenosis

Interventions

DEVICE

Navitor Transcatheter Aortic valve and FlexNav Delivery system

Navitor valve is indicated for transcatheter delivery in patients with symptomatic severe native aortic stenosis who are intermediate or low surgical risk. Subjects will undergo transcatheter aortic valve replacement (TAVR) with the Navitor valve and FlexNav Delivery system.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Stephen Worthley, M.D., Ph. D. · Macquarie University Hospital

  • Nicolas van Mieghem, M.D., Ph. D. · Erasmus Medical Center

  • Barathi Sethuraman · Abbott

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-13
Primary Completion
2025-01-02
Completion
2036-02-28
FDA Device
Yes

Countries

  • Australia
  • Austria
  • Denmark
  • France
  • Germany
  • Israel
  • Italy
  • Netherlands
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04788888 on ClinicalTrials.gov